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HER2-positive Breast Cancer clinical trials
28 of 55 indexed HER2-positive Breast Cancer trials are currently recruiting.
55 US clinical trials · 28 currently recruiting
HER2-positive Breast Cancer is the subject of 55 registered US clinical trials on ClinicalTrials.gov, 28 of them currently open to new participants. 3 are in Phase 3-4 (later-stage) and 44 in Phase 1-2 (earlier-stage). The most active sponsor is H. Lee Moffitt Cancer Center and Research Institute, running 7 of these trials.
The research picture
HER2-positive Breast Cancer has 55 registered US clinical trials, 28 of them open to new participants right now, about 51% of the total.
- 28
- recruiting participants now
- 51%
- of trials open to enrollment
- 3
- in Phase 3–4 (later-stage)
- 7
- top sponsor: H. Lee Moffitt Cancer Center and Research Institute
Active & Recent Trials
55 total, page 1 of 2
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
QuantumLeap Healthcare Collaborative
NCT01042379
Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer
NRG Oncology
NCT05705401
ATEMPT 2.0: Adjuvant T-DM1 vs TH
Dana-Farber Cancer Institute
NCT04893109
A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer
Dana-Farber Cancer Institute
NCT04569747
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
University of Miami
NCT06123988
A Phase 1/1b Study of IAM1363 in HER2 Cancers
Iambic Therapeutics
NCT06253871
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Brigham and Women's Hospital
NCT04030507
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Baylor Breast Care Center
NCT05020860
Study of Screening Brain MRIs in Stage IV Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT05115474
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
MedSIR
NCT06172127
A Study of Surgery and Radiotherapy in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT07053085
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Mersana Therapeutics
NCT05514717
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Jazz Pharmaceuticals
NCT07102381
PRE-I-SPY Phase I/Ib Oncology Platform Program
QuantumLeap Healthcare Collaborative
NCT05868226
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
Dana-Farber Cancer Institute
NCT06439693
TRUDI: TDXD+Durva in HER2+/Low IBC
Filipa Lynce, MD
NCT05795101
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission
Memorial Sloan Kettering Cancer Center
NCT07459673
Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab
H. Lee Moffitt Cancer Center and Research Institute
NCT05325632
HER-2 B Cell Peptide Vaccine
Pravin T.P Kaumaya
NCT06414733
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
H. Lee Moffitt Cancer Center and Research Institute
NCT04588545
HER2 Vaccine for Locally Advanced Breast Cancer
Pravin T.P Kaumaya
NCT06949410
Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
Ruth O'Regan
NCT04886531
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
Alison Stopeck
NCT06220214
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT05378464
BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer
University of Illinois at Chicago
NCT06441890
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
University of Alabama at Birmingham
NCT04332588
A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)
H. Lee Moffitt Cancer Center and Research Institute
NCT05809752
NearWave Optical Molecular Monitoring
Indiana University
NCT06744465
A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
Seagen, a wholly owned subsidiary of Pfizer
NCT05132582
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Seagen, a wholly owned subsidiary of Pfizer
NCT03975647
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
Enliven Therapeutics
NCT06328738
A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors
Hoffmann-La Roche
NCT05593094
MARGetuximab Or Trastuzumab (MARGOT)
Dana-Farber Cancer Institute
NCT04425018
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
University of Texas Southwestern Medical Center
NCT03747120
Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
Brigham and Women's Hospital
NCT04899908
A Prospective Study of Breast Cancer Patients With Abnormal Strain Imaging
Northwestern University
NCT02993198
Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT03384914
STOP-HER2: Stopping Trastuzumab in HER2+ MBC
Dana-Farber Cancer Institute
NCT05721248
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
City of Hope Medical Center
NCT01730833
HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT03387553
HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases
City of Hope Medical Center
NCT03696030
Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity
Memorial Sloan Kettering Cancer Center
NCT05036252
TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer
Mayo Clinic
NCT03179904
Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer
Fox Chase Cancer Center
NCT03125928
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
University of Washington
NCT03738553
Omission of Radiation in Patients With Her-2 Positive Breast Cancer
University of Kansas Medical Center
NCT03460067
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
City of Hope Medical Center
NCT02226276
HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy
Washington University School of Medicine
NCT06844669
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
Seagen
NCT02614794
PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors
Pieris Pharmaceuticals
NCT03650348
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 18 |
| Phase 2 | 26 |
| Phase 3 | 3 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the HER2-positive Breast Cancer Trial Landscape
55 indexed HER2-positive Breast Cancer studies · 28 recruiting (51%).
Phase mix: 3 late (III/IV) vs 44 early (I/II).
Top sponsor: H. Lee Moffitt Cancer Center and Research Institute (7 trials), 9 others listed. 50 shown below, recruiting first.
How to read this condition's trial landscape
That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.
Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.
All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.
Frequently Asked Questions
How many clinical trials are there for HER2-positive Breast Cancer?
PlainTrial tracks 55 US clinical trials for HER2-positive Breast Cancer, of which 28 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for HER2-positive Breast Cancer?
Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.
Is this data current?
Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.
Related
Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.
Read our methodology - how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.